Contact information

Type

Primary contact

ORCID ID

Contact details

Additional identifiers

EudraCT number

2008-001098-13

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SALLISE

Study hypothesis

Our objectives were to assess: 1. Whether intravenous (IV) levetiracetam could be administered safely in the treatment of non-convulsive status epilepticus2. Whether it was efficacious in terminating nonconvulsive status epilepticus quickly when administered together with IV lorazepam3. Whether is was efficacious in preventing relapse within 12 hours after treatment

For the Intervention group, levetiracetam (2,500 mg) will also be administered simultaneously with the lorazepam mentioned above.

For the Control group, placebo will be administered simultaneously with the lorazepam in the same manner as for the Intervention group.

Vital signs, including blood pressure, pulse and respiratory rate will be assessed before and after the lorazepam or lorazepam + levetiracetam administration, and after administration of valproate.

In this protocol, we have reduced the dose of lorazepam from the standard 0.1 mg/kg in view of side effects, including hypotension and hypoventilation in around 20% of cases. If status epilepticus was not controlled, other antiepileptic drugs will be given at the discretion of the treating neurologist. There will be no repeat administration of IV levetiracetam after 12 hours.

Intervention type

Drug

Phase

Not Specified

Drug names

Lorazepam, Levetiracetam, valproate

Primary outcome measure

Responder rate immediately after IV administration of lorazepam and before administration of valproate, comparing the group that received placebo versus the group that received levetiracetam.

Secondary outcome measures

1. Responder rate immediately after IV administration of valproate, comparing the group that received placebo versus the group that received levetiracetam2. Responder rate 12 hours after IV administration of lorazepam and valproate, comparing the group that received placebo versus the group that received levetiracetam3. Side effects 30 days after treatment4. Glasgow Outcome Scale 30 days after treatment

Overall trial start date

01/04/2008

Overall trial end date

31/03/2010

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult male and female patients 2. Nonconvulsive SE (NCSE), and more specifically, complex partial SE (CPSE) and SE in coma. NCSE is defined as a change in behaviour and/or mental status from baseline associated with electroencephalogram (EEG) changes consistent with SE. We subdivide CPSE into i) CPSE in patients with epilepsy and ii) CPSE de novo. We consider subtle SE as a subgroup of SE in coma. Subtle SE is defined as SE that evolved from convulsive seizures to seizures with minor motor manifestations, such as muscle twitches, tonic eye deviation and nystagmoid eye jerks, and ictal EEG changes.